Medical devices

Legal advice regarding medical products

Running a company operating in the medical products industry, it sometimes happens that it is difficult to keep up with constantly changing legal regulations and guidelines issued at both national and European levels; therefore, we offer our clients support in this area.

We provide advisory on:

classification of products as medical devices and assigning to the relevant class ;
in cooperation with experts, we help prepare documentation for medical devices necessary for conformity assessment
labelling of medical devices and contents of the operating instructions;
first time marketing of medical devices on the territory of Poland, including support of clients in filling in application forms and notices supplied to the President of URPLof medical;
advertising of medical devices, including providing opinions on advertisement leaflets;
marketing of medical devices, including providing opinions on advertisement leaflets;
contracts for the production of medical devices and their distribution;
reimbursement of medicines and medical devices;
Internal training related to first-time marketing of medical devices.

Medical Devices – Notifications

Introducing medical devices to market is a complex process that requires meeting numerous formal and regulatory requirements. Every manufacturer and distributor must ensure that their products meet applicable requirements, including documentation, to ensure patient safety and avoid potential negative legal consequences. One of the most important steps in this process is proper notification of the medical device introduction to the market.

It’s important to remember that regulations regarding medical devices vary depending on country and region. In the European Union, the Medical Device Regulation (MDR) has tightened requirements for classification, certification, and technical documentation. To meet these requirements and avoid procedural errors, many manufacturers choose to collaborate with legal experts specializing in these areas.

Why is it worth choosing legal advice regarding medical devices?

Companies that use legal advice regarding medical devices canexpect:

faster product launch due to efficient documentation preparation and formally correct notification,
minimizing the risk of errors that could result in administrative penalties or product withdrawal from the market,
adaptation to dynamically changing regulations, both in Poland and on foreign markets,
legal protection in the case of inspections or potential disputes with regulators.

Food&Pharma Legal supports its clients at every stage of the process – from the initial planning of the market strategy, through supervision of the product documentation and labeling, to its introduction to the market and advertising.

Classification of products into group of medical devices

Correctly classifying products as medical devices is crucial for compliance with applicable legal regulations. This process requires a detailed analysis of the product, its declared purpose, and, crucially, product documentation. Food & Pharma Legal supports manufacturers and distributors in the qualification process, helping to avoid errors that could result in legal consequences or product recalls.